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Generated: October 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201209

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NDA 201209 describes BENZONATATE, which is a drug marketed by Apotex Inc, Bionpharma Inc, Cspc Nbp Pharm Co, Mikart, Nesher Pharms, Orit Labs Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from sixty suppliers. Additional details are available on the BENZONATATE profile page.

The generic ingredient in BENZONATATE is benzonatate. There are six drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 201209
Tradename:BENZONATATE
Applicant:Thepharmanetwork Llc
Ingredient:benzonatate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201209
Suppliers and Packaging for NDA: 201209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 201209 ANDA Ascend Laboratories LLC 67877-128 67877-128-01 100 CAPSULE in 1 BOTTLE (67877-128-01)
BENZONATATE benzonatate CAPSULE;ORAL 201209 ANDA Ascend Laboratories LLC 67877-128 67877-128-05 500 CAPSULE in 1 BOTTLE (67877-128-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Sep 24, 2014TE:AARLD:No

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